Home NDC 80610-430-60 ZORYVE
Product NDC 80610-430
Requested package NDC 80610-430-60
11-digit product format 806100430
Labeler code 80610
Product ID 80610-430_71b48a15-8cac-46b2-81ad-3aaae6049db5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name roflumilast
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Arcutis Biotherapeutics, Inc.
Application NDA217242
Marketing category NDA
Marketing start 2023-12-15
Substance ROFLUMILAST
Active strength 3 mg/g
Pharmacologic classes Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80610-430 80610-430-60 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217242-001 ZORYVE ROFLUMILAST 0.3% FOAM / TOPICAL RLD, RS 2023-12-15
Orange Book patents# Current patent rows page 1 of 1 · 27 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217242-001 NP 2026-12-15 N217242-001 I-969 2028-05-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 325 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N217242-001 10940142 2037-06-07 Drug product 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11793796 2037-06-07 Drug product 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11819496 2037-06-07 U-4203 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11819496 2037-06-07 U-3773 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11992480 2037-06-07 U-4203 2024-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11992480 2037-06-07 U-3773 2024-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12005051 2037-06-07 U-4203 2024-07-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12005051 2037-06-07 U-3773 2024-07-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12005052 2037-06-07 Drug product 2024-07-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12011437 2037-06-07 Drug product 2024-07-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12016848 2037-06-07 Drug product 2024-07-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12042487 2037-06-07 Drug product 2024-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12220409 2037-06-07 Drug product 2025-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12257242 2037-06-07 Drug product 2025-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12310956 2037-06-07 U-3773 2025-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12310956 2037-06-07 U-4203 2025-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12336983 2037-06-07 Drug product 2025-07-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12390453 2037-06-07 Drug product 2025-09-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12697329 2037-06-07 Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 9884050 2037-06-07 Drug product 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 9907788 2037-06-07 U-4203 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 9907788 2037-06-07 U-3773 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11129818 2037-08-25 U-4203 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11129818 2037-08-25 U-3773 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 11707454 2041-12-03 U-3773 2023-12-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12329751 2041-12-03 U-3773 2025-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217242-001 12453721 2042-08-19 Drug product 2025-11-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217242-001 10940142 2037-06-07 Drug product 2023-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 11793796 2037-06-07 Drug product 2023-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 11819496 2037-06-07 U-4203 2023-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 11819496 2037-06-07 U-3773 2023-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 11992480 2037-06-07 U-4203 2024-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 11992480 2037-06-07 U-3773 2024-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12005051 2037-06-07 U-4203 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12005051 2037-06-07 U-3773 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12005052 2037-06-07 Drug product 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12011437 2037-06-07 Drug product 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12016848 2037-06-07 Drug product 2024-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12042487 2037-06-07 Drug product 2024-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217242-001 12220409 2037-06-07 Drug product 2025-03-07 84e616aacf4f…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ZORYVE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROFLUMILAST 3 mg/g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80610-430-60 ZORYVE 60 g in 1 CAN AEROSOL, FOAM 60 6 80610-430-60 ZORYVE 1 in 1 CARTON AEROSOL, FOAM 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80610-430 ZORYVE (ROFLUMILAST) AEROSOL, FOAM [ARCUTIS BIOTHERAPEUTICS, INC.] 4 Current NDC, 2 package rows 20250529_f9e0b4a9-a227-4947-b00c-41fb18d16589.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80610-430-60 80610043060 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN 1 can 2023-12-15 No No Current